cGMP Food Packaging Audit & Certification Services

Kiwa ASI's cGMP Food Packaging Audit is a HACCP-based third-party assessment that verifies your packaging facility meets current Good Manufacturing Practices (cGMP) under 21 CFR Part 117, protecting your products, your customers, and your brand.

HACCP-Based
21 CFR 117 Aligned
Annual Certification

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What Is a cGMP Food Packaging Audit?

A cGMP food packaging audit is a HACCP-based third-party assessment designed to verify that food packaging manufacturing facilities meet the basic food safety and food defense requirements of retailers, regulatory agencies, and the general public. Benchmarked against 21 CFR Part 117, it is one of the most comprehensive audit programs available for the food packaging industry.

Kiwa ASI's cGMP Food Packaging Audit Program (Version 2.0, effective January 2026) provides a comprehensive framework for evaluating the competence of a facility's food safety management system, its documented procedures, and the effectiveness of those procedures in controlling and mitigating food safety and food defense risks. The audit criteria are founded on 21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, while integrating globally recognized industry best practices that exceed baseline regulatory requirements.

Though primarily framed around cGMP standards, the audit also incorporates principles from cGDP (Current Good Distribution Practices) and cGSP (Current Good Storage Practices) when assessing broader supply chain and logistical activities, giving you a holistic evaluation of your food packaging safety systems.

HACCP-Based Framework

Systematically identifies and controls biological, chemical, and physical hazards in packaging operations.

21 CFR 117 Aligned

Audit criteria built directly on FDA's current Good Manufacturing Practice regulations for human food.

Three-Module Assessment

Evaluates Food Safety Management System, cGMP operations, and HACCP plan in a single comprehensive audit.

Annual Certification

Scored audit with Excellent, Good, or Complies ratings — renewable every 12 months.

WHO IT'S FOR

Who Needs a cGMP Food Packaging Audit?

The cGMP Food Packaging Audit applies to any facility that handles, manufactures, processes, stores, or distributes food or food contact packaging products. If your operation produces materials that come into contact with food at any point in the supply chain, this audit is designed for you.

Food Packaging Manufacturers Food Contact Product Converters Packaging Warehouses & Distribution Centers Co-Packers & Contract Manufacturers Raw Material Suppliers

Many major food retailers and brand owners now require their packaging suppliers to hold a recognized third-party food safety audit. A cGMP certification from Kiwa ASI demonstrates that your facility operates under verified food safety controls — helping you meet customer requirements, protect consumers, and maintain market access.

All facilities located inside the United States, or facilities outside the United States that export to the U.S., must also meet all applicable FDA and USDA regulatory requirements. International facilities must meet regulatory requirements for where the product is manufactured and/or sold.

ADVANTAGES

What Are the Advantages of cGMP Food Packaging Certification?

Achieving cGMP certification through Kiwa ASI provides food packaging manufacturers with a verified standard of food safety excellence that meets retail buyer expectations and regulatory alignment.

Retail & Buyer Access

Major food brands and retailers increasingly require their packaging suppliers to hold a third-party food safety audit. A cGMP certification opens doors to new business and protects existing customer relationships.

Regulatory Alignment

The audit criteria are built on 21 CFR Part 117, ensuring your facility's practices align with FDA requirements for current Good Manufacturing Practices, hazard analysis, and risk-based preventive controls.

Reduced Food Safety Risk

The HACCP-based approach systematically identifies and controls biological, chemical, and physical hazards — from foreign matter detection to allergen management and environmental monitoring.

Supply Chain Confidence

Certification provides documented assurance to your customers that food contact products are manufactured, stored, and distributed under controlled conditions that protect product integrity.

Continuous Improvement

Annual audit cycles drive ongoing improvement to your food safety management system. Each audit identifies strengths and areas for enhancement, building a culture of food safety excellence over time.

Comprehensive Coverage

The audit evaluates your entire operation across three modules — Food Safety Management System, cGMP practices, and HACCP — plus food defense, traceability, and recall readiness in a single assessment.

What Does a cGMP Food Packaging Audit Cover?

The Kiwa ASI cGMP Food Packaging Audit is structured around three core modules that evaluate every critical aspect of your food safety management system. The audit also includes a live mock recall exercise that must be completed in under two hours during the auditor's visit.

MODULE 1

Food Safety Management System

Management commitment to food safety, complaint management, document control, training programs, licensing, and certification integrity. This module evaluates the foundational elements of your facility's food safety infrastructure.

MODULE 2

Current Good Manufacturing Practices (cGMP)

The largest module of the audit, covering 15 critical operational areas including processing controls, foreign matter prevention, sanitation, pest control, chemical management, and facility design.

MODULE 3

HACCP Plan

Assessment of your Hazard Analysis and Critical Control Points system — including HACCP team, product descriptions, process flow diagrams, hazard analysis, CCPs, monitoring, and corrective actions.

FOOD DEFENSE

Food Defense & Threat Assessment

Food defense plan documentation, threat assessments, visitor management, personnel screening, secure receipt and transportation protocols, and intentional adulteration prevention.

TRACEABILITY

Traceability & Recall Readiness

Lot identification, one-step-forward and one-step-back traceability, documented recall procedures, and a live mock recall exercise completed in under two hours during the audit.

COMPLIANCE

FSMA & Regulatory Integration

Facilities subject to FSMA must maintain a documented Food Safety Plan overseen by a designated Preventive Controls Qualified Individual (PCQI) with valid PCQI training certification.

How Should You Prepare for a cGMP Food Packaging Audit?

Proper preparation is the foundation of a successful cGMP food packaging audit. Here is a step-by-step roadmap to help your facility get ready — whether this is your first audit or an annual recertification.

Review the cGMP Audit Criteria

Thoroughly review all three modules of Kiwa ASI's cGMP Audit Criteria — Food Safety Management System, cGMP practices, and HACCP — and incorporate the requirements into your food safety management program. Contact Kiwa ASI to request the current audit standard document.

Conduct an Internal Audit

Perform an internal self-assessment using the cGMP Audit Criteria as your checklist. Identify gaps in your documentation, facility conditions, or operational practices. Alternatively, order a Mock Audit from Kiwa ASI for an unscored, expert-led pre-assessment.

Build and Update Your Documentation

Ensure all required documented procedures are current, approved, and accessible — including your HACCP plan, food defense plan, cleaning and sanitation program, supplier approval records, training matrices, and recall procedures.

Train Your Team

Verify that all personnel have received appropriate training on cGMPs, HACCP, food defense, allergen management, and their role-specific responsibilities. Ensure training records are up to date and include competency verification signatures. Explore Kiwa ASI's training programs.

Test Your Traceability and Recall System

Run a mock recall exercise internally — tracing one step back to suppliers and one step forward to customers — and complete it within two hours. During the audit, the auditor will require your facility to complete a live mock recall exercise in under two hours.

Ensure 60 Days of Production Records

Your facility must have a minimum of 60 days of production records before the certification audit. If your site cannot provide 60 days of records, Kiwa ASI holds sole discretion to continue or abort the audit.

Apply and Schedule Your Kiwa ASI Audit

Submit your application to Kiwa ASI, finalize facility details, personnel, and scope information, and coordinate scheduling with the Kiwa ASI Planning team. Your facility must be in active production on the day of the audit.

Why Choose Kiwa ASI for Your cGMP Food Packaging Audit?

Kiwa ASI brings nearly a century of food safety auditing experience to the packaging industry. Here's what sets us apart:

Experience

Packaging Industry Expertise

Our auditors understand the unique challenges of food packaging manufacturing — from foreign matter controls and environmental monitoring to supply chain traceability for food contact materials. You'll work with auditors who speak your industry's language.

Standards

Comprehensive, Standards-Driven Program

The cGMP Food Packaging Audit Program (Version 2.0) was built on 21 CFR Part 117 and integrates globally recognized best practices. It covers your food safety management system, cGMP operations, and HACCP plan in a single, rigorous assessment.

Preparation

Mock Audits and Pre-Assessments

First-time applicants or facilities looking to strengthen their food safety systems can request an optional Mock Audit — an unscored, feedback-driven assessment that highlights compliance gaps before the official certification audit.

Support

Clear Communication and Support

From application through certification, Kiwa ASI's planning team coordinates every step — aligning audit scheduling with your production cycle, assigning qualified auditors to your scope, and providing clear, actionable findings.

Partnership

Global Kiwa Network

As part of the global Kiwa group, Kiwa ASI offers the scale and resources of an international certification body with the personalized service and accessibility of a domestic partner. Whether your facility is in the U.S. or exporting internationally, we ensure consistent audit quality.

Frequently Asked Questions

What is a cGMP food packaging audit?

A cGMP food packaging audit is a HACCP-based, third-party assessment that evaluates whether a food packaging manufacturing facility meets current Good Manufacturing Practices (cGMP) as defined by 21 CFR Part 117. The audit covers three modules — Food Safety Management System, cGMP operational practices, and HACCP — and results in a scored certification valid for one year.

Who needs a cGMP food packaging certification?

Any facility that manufactures, processes, stores, or distributes food or food contact packaging products can benefit from cGMP certification. Many major food brands and retailers require their packaging suppliers to hold a recognized third-party food safety audit. The certification applies to packaging manufacturers, converters, warehouses, co-packers, and raw material suppliers for food contact applications.

How long does a cGMP food packaging audit take?

The minimum duration for a certification audit is one full day (approximately 8 hours). Actual audit duration varies based on facility size, number of employees, product types, number of HACCP plans, and the overall scope of the audit. Kiwa ASI will provide a duration estimate during the application process, and audits are coordinated in half-day increments.

How often do I need to be audited?

cGMP audits are conducted annually to maintain certification. Your certificate expires 30 days after the one-year anniversary of your last certification audit. It's important to schedule audits with sufficient lead time to avoid a certificate lapse, as the technical review and approval process may extend beyond the expiration date.

Can I get a mock audit before my official certification audit?

Yes. Kiwa ASI offers optional Mock Audits — unscored pre-assessments that provide valuable feedback on compliance gaps. Mock audits help first-time applicants and existing certified sites identify areas for improvement before the scored certification audit. A Mock Audit cannot be converted into a scored Certification Audit once it has begun.

What score do I need to pass the cGMP audit?

Your facility needs a score of 70% or higher to receive a certificate. Scores of 90–100% earn an Excellent rating, 80–89% earn a Good rating, and 70–79% earn a Complies rating. A critical non-conformity (such as active contamination or falsification of records) results in an automatic score of 0% and no certificate is issued.